Which CLIA Certificate Do I Need?
Answer up to four plain questions about your test menu and how you want to be surveyed. You get the CLIA certificate type, the part of 42 CFR 493 that governs it, the CMS fee, how long it lasts, who surveys it and the form to file next. It runs in your browser and sends nothing.
Which CLIA certificate — assaydeck.com
Certificate finder
Four questions at most. Your answers stay in this browser tab.
Question 1 of up to 4
Bench sheet
- Waived tests only–
- PPM only, by a provider–
- Most complex test–
- Accreditor–
- Certificate–
- CMS fee–
- FormCMS-116 (03/24)
What the finder decides
CLIA sorts every test into waived, moderate complexity (with provider-performed microscopy as a subcategory) or high complexity (§ 493.5(a)). The certificate follows the most complex test on your menu. CMS puts it in one line: "All certificate types allow waived testing to be performed; however, the certificate a laboratory obtains must be for the most complex category of testing the laboratory performs."
So the questions run from the simplest menu up. A waived-only menu stops at the first question. A menu whose only non-waived work is a provider's microscopy stops at the second. Anything else needs a Certificate of Registration first, and the last question decides whether the State Agency or an accreditor confirms you after that.
Worked example: five labs
The first row uses only tests from the waived list in § 493.15(c); the second only procedures from the PPM list in § 493.19(c). The third row shows why the person at the microscope matters: PPM must be "personally performed" by a physician, midlevel practitioner or dentist.
| Lab and menu | Certificate | First CMS fee |
|---|---|---|
| Family practice: dipstick urinalysis, visual urine pregnancy tests, fecal occult blood | Waiver | $248 |
| OB/GYN practice adds wet mounts and fern tests the physician reads during the visit | PPM | $297 |
| The same practice, but a medical assistant reads the wet mounts | Registration, then Compliance or Accreditation | $123 first |
| Physician office lab adds a moderate complexity chemistry analyzer, State Agency survey | Registration, then Compliance | $123 first |
| Independent lab running high complexity molecular tests, accredited by CAP | Registration, then Accreditation | $123 first |
Fees from the CMS fee schedule (updated 2024), read 2026-10-23. After registration, compliance and accredited labs pay a certificate fee plus a survey or validation fee set by annual test volume; the lowest band is Low Volume A (Schedule V in the regulation), 2,000 or fewer tests a year.
What 42 CFR 493 says
Each laboratory must be either CLIA-exempt or possess one of the following CLIA certificates
The five it lists are the certificate of registration, of waiver, for PPM procedures, of compliance and of accreditation. Registration is never the end state. It lets a lab run moderate or high complexity tests "until the entity is determined to be in compliance through a survey" (§ 493.2), lasts "no more than two years or until such time as an inspection … can be conducted, whichever is shorter", and is "Not renewable" (§ 493.45(e)).
An accreditation lab must show CMS proof of accreditation within 11 months of its registration certificate, or meet the compliance route instead (§ 493.57(b)). Waiver and PPM labs are "not subject to biennial inspections" (§ 493.1775(a)), though CMS may still visit on a complaint.
Changing certificate type later
New York and Washington run their own HHS-approved programs, so labs there start with the state program. Everywhere else, the next step is the application: how to get a CLIA certificate, step by step.